1. Field of the Invention PA1 Endotracheal intubation is a medical procedure which concerns the placement of a tube in the trachea of a patient to facilitate breathing or to permit the controlled introduction of certain gasses through the tube by an anesthesiologist, or other medical personnel for appropriate purposes. In the past, endotracheal intubation only has been attempted and accomplished under controlled circumstances which were not acute, i.e., where no immediate medical emergency existed. For instance, uncuffed tracheotomy tubes were used to provide an airway in patients during the Scandinavian polio epidemic of 1952. Unfortunately, the use of these essentially plain tubes was not particularly successful and the mortality rate was approximately eighty percent at the beginning of the use of the tubes. By using a cuffed endotracheal tube and a proper ventilator in conjunction with the tube, the mortality rate was lowered to approximately thirty percent.
The present invention relates to apparatuses for endotraceal intubation, and more particularly to a medical instrument which facilitates endotracheal intubation by simultaneously providing visualization of the intubation as well as controlled delivery of gas and suction at the end of an obturator which carries the endotracheal tube.
2 Description of the Prior and Contemporary Art
In the midfifties, a branch of medicine called "critical care medicine" began to develop. Critical care medicine is concerned with treatment of acute patients who have been the victims of serious accidents or the like. To cater to critical care patients, intensive care units have been opened in many hospitals. For instance, the intensive care unit at Baltimore City Hospital opened in 1958 and the intensive care unit opened at Massachusetts General Hospital in 1961. Typically, the patients in these units are critically ill following surgery, accident induced trauma, or acute infectious processes.
Trauma is the leading cause of death in the U.S. in patients between the ages of one and forty. Twenty million people will seek emergency room treatment this year, over one hundred and fifty thousand of whom will die from their injuries. A common type of trauma is face trauma wherein the airway function of the patient is compromised. This causes the aspiration of blood or vomitus and results in ventilatory or pulmonary complications. As a result, the most common causes of trauma related deaths are inadequate ventilation, inadequate circulation, or more massive hemorrhage for which there is little recourse. As critical care medicine developed, acute resuscitation techniques were established. Respiratory resuscitation started developing in the 1950's. External cardiac and cardo-pulmonary resuscitation developed in the 1960's. Proper ventilation is critical as pointed out by Doctors Weil and Shubin, former Directors of intensive care at the University of California and the founders of the Society of Critical Care Medicine. The doctors stated that the first priority among the primary functions which determine survival in all critical care units is the maintenance of ventilation and gas exchange.
Despite this development in critical care medicine, no heretofore satisfactory method of ventilation has been developed and despite the recognition of the importance of maintaining ventilation and gas exchange, devices known in the prior art have not satisfactorily accomplished this task. In Vietnam, for example, asphyxiation from upper airway obstruction or injury was a common cause of death in the field or enroute to forward surgical facilities.
It therefore can be concluded that priorities in critical care medicine must respond to airway management, breathing and circulatory problems and that the efficiency of airway management is essential to optimal circulatory resuscitation. Unfortunately, hardware development in this area has been virtually arrested in terms of development of a single instrument which can provide all the necessary functions. No instrument presently available provides visualization of the airway and airway access in acute resuscitation, the ability to suck debris to avoid aspiration and to assist in obtaining visualization, means for providing ventilation capabilities and also means for carrying and inserting a suitable airway tube in position. Presently, in order to obtain and maintain a properly functioning airway, at least two instruments are required for placement of an endotracheal tube, unless blind insertion of the tube is attempted. The blind insertion of the tube, that is the placement of a tube on a suitable obturator and the insertion of the obturator without visualization, leads to numerous lethal complications. Specifically, the location and passage of the tube cannot be visualized and there is no way to provide ventilation, the much needed reason for placing the tube to begin with, while the tube is being positioned. In some instances, placement of a tube has been enhanced by the use of a laryngoscope which permits entry of the tube and an obtruator which includes an optical stylet for introducing the tube. The use of a laryngoscope along with an obturator and an optical stylet or endoscope requires multi-handed, complicated manipulation of several instruments at once with the critically situated patient being the loser for the inefficiency of such procedures.
Specifically surveying the prior art, a larynogoscope with illumination means is shown in U.S. Pat. No. 2,646,036 and an endoscope with illumination means can be found in U.S. Pat. No. 3,269,387. Intubating stylets, i.e., fixtures for carrying thereon tubes to facilitate the insertion thereof, can be found in U.S. Pat. Nos. 2,463,149 and 2,541,402. Bronchoscopy tubes which permit delivery of a fluid or oxygen during use are shown in U.S. Pat. Nos. 4,041,936; 3,941,120; 3,850,162; 3,460,541; 3,348,542; 3,175,557; 2,705,959; 4,090,518; and 4,146,019. U.S. Pat. Nos. 2,912,982 and 3,087,493 teach endotracheal tubes which permit gas suctioning and gas delivery.
Surgical endoscopes which provide illumination means in addition to a telescope and which in some instances provide for the delivery of fluids or suction are shown in U.S. Pat. Nos. 3,830,225; 3,572,325; 3,162,190; 2,704,541; and 2,129,391. None of these devices, however, show or suggest the use of an endotracheal tube therewith and each of these apparatuses can only accomplish its function when in position, with tubal ventilation upon removal not being possible.
U.S. Pat. No. 3,147,746 teaches an illuminating endoscope which permits intubation, but does not permit simultaneous use of an obturator and visualization. As a result, the obturator is used to place the device in position and only then can visualization take place after the obturator is removed.
A similar apparatus wherein an obturator must be removed from a tube so that visualization by a scope can take place is shown in U.S. Pat. No. 3,081,767.
U.S. Pat. No. 3,677,262 shows a surgical instrument which permits endotracheal intubation simultaneously with visualization. No means are shown or suggested for accomplishing ventilation during intubation nor are means shown or suggested for selectively retaining and/or ejecting the tube during the intubation process.
After reviewing the aforegoing, it is obvious that there has been quite a bit of activity in the field of endotracheal intubation. Nonetheless, no one heretofore has provided an apparatus which integrates all the necessary and desirable features into a single instrument which accomplishes intubation in a safe and optimumly fast way despite all the activity in this area and recent growing emphasis in critical care medicine.
Despite this intense emphasis on critical care medicine since the early 1970's, no one has developed an integrated instrument for safely and quickly placing an endotracheal tube. With this as a backdrop, the present invention overcomes the shortcomings of the prior art by providing a medical instrument for facilitating endotracheal intubation or the like which, in a single integrated, apparatus, provides light and visualization for placement of an endotracheal tube, an obturator for support of the endotracheal tube, suction to enhance visualization and to preclude asphyxiation, and a ventilation source so that rapid airway gas exchange can take place. All this has been integrated into a single instrument which can be used with one hand providing for "fast" in and out so that the maximum number of patients can be aided with the lowest possible morbidity.